New Medtronic Heart Valve Threatened By Court Decision

A legal injunction may severely limit the availability in the United States of Medtronic's CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery.

The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder Medtronic from competing in the US and international markets. This particular case was initiated in 2008. In 2010 a federal jury' decided that Medtronic had infringed Edwards' Andersen transcatheter aortic valve replacement patent. The decision was affirmed by the Court of Appeals. The Supreme Court declined to review the case.

Although the judge accepted Medtronic's contention that CoreValve has important clinical benefits he ultimately sided with Edwards. Here is the key passage in the judge's oral decision on Friday.

Regarding the public interest factor, the Court is persuaded that there are patients who cannot be served by either the Sapien or Sapien XT and who need the CoreValve Generation 3. The Court is also convinced that the CoreValve Generation 3 is a safer device and that patients in whom it is implanted have better outcomes with a lower risk of death. At the same time, the Court cannot downplay the strong public interest favoring enforcement of patent rights. Thus, the Court finds that the public interest weighs in favor of granting Edwards a preliminary injunction, but that Medtronic must be allowed to sell its devices to those patients who cannot be helped by Edwards'devices.

The judge ordered the two companies to negotiate an arrangement so that CoreValve could continue to be used in US centers currently trained on CoreValve. The judge also agreed to postpone implementation of the injunction for one week in order to allow Medtronic a chance to appeal the injunction. (On Monday, according to Fierce Medical Devices, Medtronic filed its motion to postpone the injunction and appeal the ruling.)

Wells Fargo analyst Larry Biegelsen estimated that if the injunction is upheld CoreValve will be limited to about 15% of the US market until patent expiration in March 2016.

The Wall Street Journal interviewedJohn Carroll, the director of interventional cardiology at the University of Colorado Hospital, which uses the Sapien valve but had planned to start training to use the CoreValve as well. Carroll told the WSJ that Medtronic had put the training program on hold. "It's a shock because the device has been approved and is being used commercially," said Carroll.

I asked David Kandzari, the director of international cardiology at the Piedmont Heart Institute, for some additional perspective. He noted that there are additional patent cases that could threaten CoreValve. "In short, the story is not over, even after this story is over," he said.

Referring to the historical precedent of drug-eluting stents, Kandzari suggested the two companies might ultimately reach a financial arrangement which would allow CoreValve a significant presence on the market. Edwards, he suggested, could damage itself by seeking extreme limitations on CoreValve availability:

As much as this is unfavorable for Medtronic, it also represents a public relations dilemma for Edwards. In other words, do they appear to be suppressing a valuable technology for their own self interest, or alternatively, do they show goodwill with some agreement for CoreValve to remain on the US market?